US11065061B2ExpiredUtilityA1

Systems and methods for performing image guided procedures within the ear, nose, throat and paranasal sinuses

94
Assignee: ACCLARENT INCPriority: Apr 21, 2004Filed: Mar 29, 2016Granted: Jul 20, 2021
Est. expiryApr 21, 2024(expired)· nominal 20-yr term from priority
Inventors:Joshua Makower
A61B 90/16A61B 2017/00787A61B 18/02A61B 2090/365A61B 5/6851A61B 50/13A61B 90/36A61B 90/361A61B 2090/3983A61B 2034/2055A61B 18/20A61B 2034/107A61B 2034/105A61B 2034/2048A61B 2034/2051A61B 2034/2065A61M 25/09A61B 6/032A61B 34/20A61M 2210/0681A61B 6/037A61M 2029/025A61B 2034/2074A61B 5/062A61B 1/233A61B 6/463A61M 29/02
94
PatentIndex Score
17
Cited by
1,450
References
20
Claims

Abstract

Devices, systems and methods for performing image guided interventional and surgical procedures, including various procedures to treat sinusitis and other disorders of the paranasal sinuses, ears, nose or throat.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A method for image guided performance of a treatment procedure to treat an ear, nose, throat or paranasal sinus in a patient, the method comprising:
 (a) using a monitor of an image guidance system to view an image of the patient's head; 
 (b) calibrating the position of the patient's head using a plurality of fiducial markers; 
 (c) using the monitor of the image guidance system to view the positions of the fiducial markers relative to the image of the patient's head; 
 (d) coupling a first working device to a computer of the image guidance system, wherein the first working device comprises a sensor at a distal end portion of the first working device, wherein the first working device communicates at least one calibration detail to the computer upon being coupled thereto; 
 (e) operating a transmitter assembly positioned outside of the patient's head to emit an electromagnetic field; 
 (f) inserting the first working device into the patient's head through the patient's nostril so that the sensor is within the patient's head; 
 (g) determining a position of the sensor within the patient's head based upon an interaction of the sensor with the electromagnetic field and the at least one calibration detail and viewing a portion of the first working device on the monitor relative to the image of the patient's head based on the position of the sensor; and 
 (h) using at least the first working device to treat the ear, nose, throat, or paranasal sinus of the patient while viewing the monitor, 
 wherein using at least the first working device to treat the ear, nose, throat, or paranasal sinus of the patient comprises dilating an anatomical passageway within the ear, nose, or throat of the patient. 
 
     
     
       2. The method of  claim 1 , further comprising scanning the patient's head prior to a procedure to obtain an image of the patient's head. 
     
     
       3. The method of  claim 1 , wherein the at least one calibration detail comprises a distance between the sensor and another portion of the first working device. 
     
     
       4. The method of  claim 3 , wherein the at least one calibration detail comprises a position of the sensor relative to the distal end portion of the first working device. 
     
     
       5. The method of  claim 1 , wherein the at least one calibration detail comprises a length of at least a portion of the working device. 
     
     
       6. The method of  claim 1 , wherein the at least one calibration detail comprises a baseline output of the sensor. 
     
     
       7. The method of  claim 1 , wherein the at least one calibration detail is stored on a readable device on the first working device. 
     
     
       8. The method of  claim 7 , wherein the readable device comprises a radio-frequency identification tag, the method further comprising automatically reading the at least one calibration detail from the radio-frequency identification tag after coupling the first working device to the computer. 
     
     
       9. The method of  claim 1 , wherein coupling the first working device to the computer comprises physically and electronically coupling the first working device to the computer via a wire. 
     
     
       10. The method of  claim 1 , further comprising inserting an endoscope into the patient's head through the patient's nostril to directly visualize the first working device within the patient's head. 
     
     
       11. The method of  claim 10 , further comprising, while viewing the image of the patient's head on the first monitor, using a second monitor that is communicated with the endoscope to view images captured by the endoscope of the first working device within the patient's head, wherein the image of the patient's head on the first monitor is a preoperatively captured image. 
     
     
       12. The method of  claim 1 , further comprising:
 (a) inserting a second working device into the patient's head through the patient's nostril; and 
 (b) viewing a portion of the second working device on the monitor relative to the image of the patient's head and relative to the sensor. 
 
     
     
       13. The method of  claim 12 , wherein the first working device comprises a guide tube, wherein the second working device comprises a balloon catheter, wherein inserting the second working device into the patient's head through the patient's nostril comprises inserting the balloon catheter through the guide tube. 
     
     
       14. The method of  claim 13 , wherein treating the ear, nose, throat, or paranasal sinus of the patient comprises dilating a sinus ostium with the balloon catheter. 
     
     
       15. The method of  claim 1 , further comprising inserting a guidewire into the patient's head prior to inserting the first working device, wherein the guidewire comprises a second sensor configured to interact with the electromagnetic field when positioned inside the patient's head. 
     
     
       16. The method of  claim 15 , wherein inserting the first working device into the patient's head comprises inserting the first working device over the guidewire. 
     
     
       17. A method for image guided performance of a treatment procedure to treat an ear, nose, throat or paranasal sinus in a patient, the method comprising:
 (a) using a monitor of an image guidance system to view an image of the patient's head; 
 (b) calibrating a position of the patient's head using a plurality of fiducial markers; 
 (c) using the monitor of the image guidance system to view the positions of the fiducial markers relative to the image of the patient's head; 
 (d) coupling a guidewire to a computer of the image guidance system, wherein the guidewire comprises a first sensor, wherein the guidewire communicates at least one calibration detail associated with the guidewire to the computer upon being coupled thereto; 
 (e) operating a transmitter assembly positioned outside of the patient's head to emit an electromagnetic field; 
 (f) inserting the guidewire into the patient's head through the patient's nostril; 
 (g) coupling a balloon catheter to the computer, wherein the balloon catheter comprises a second sensor, wherein the balloon catheter communicates at least one calibration detail associated with the balloon catheter to the computer upon being coupled thereto; 
 (h) viewing a portion of the guidewire on the monitor relative to the image of the patient's head based on the at least one calibration detail associated with the guidewire and a position of the first or second sensor that is determined based upon an interaction of that sensor with the electromagnetic field; 
 (i) viewing a portion of the balloon catheter on the monitor relative to the image of the patient's head based on the at least one calibration detail associated with the balloon catheter and a position of the first or second sensor that is determined based upon an interaction of that sensor with the electromagnetic field; and 
 (j) treating the ear, nose, throat, or paranasal sinus of the patient with the balloon catheter, wherein treating the ear, nose, throat or paranasal sinus of the patient with the balloon catheter comprises dilating an anatomical passageway within the ear, nose, or throat of the patient. 
 
     
     
       18. A method for image guided performance of a treatment procedure to treat an ear, nose, throat or paranasal sinus in a patient, the method comprising:
 (a) loading scan image data of a patient's head onto a computer of an image guidance system; 
 (b) displaying a scan image from the scan image data on a monitor of the image guidance system; 
 (c) loading calibration details associated with one or more working devices onto the computer; 
 (d) inserting a first working device of the one or more working devices into the patient's head, wherein the first working device comprises a guidewire and a first sensor positioned at a distal tip of the guidewire; 
 (e) inserting a second working device of the one or more working devices into the patient's head, wherein the second working device comprises a second sensor; 
 (f) operating a transmitter assembly positioned outside of the patient's head to emit an electromagnetic field; 
 (g) determining the positions of at least one of the first and second sensors based upon an interaction of that sensor with the electromagnetic field; and 
 (h) viewing the guidewire and the second working device on the monitor relative to the scan image based on the calibration details and positions of at least one of the first and second sensors, wherein the second working device comprises a balloon catheter, the method further comprising dilating an anatomical passageway within the ear, nose, or throat of the patient with the balloon catheter. 
 
     
     
       19. The method of  claim 18 , further comprising advancing the second working device along the guidewire. 
     
     
       20. The method of  claim 18 , wherein the second working device comprises a balloon catheter, the method further comprising dilating an anatomical passageway within the ear, nose, or throat of the patient with the balloon catheter.

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